I’ve struggled with what to say about this subject for two weeks, because I want to “get it right” but it’s vast. So I’m giving up any hope of being comprehensive, and I’m just going to say what little I know, and what I think, and let any discussion happen from there.The issue

We (the US, and probably the world) are at a pivotal moment in healthcare, a turning point. The direction we choose now can have a lasting effect on how well healthcare works in the coming years – even for the next decade, I suspect. So as we consider this, I suggest that we think not in 2010 terms, but 2020 terms.

The issue at hand is the definition of “meaningful use.” You’ve probably heard of the $19B in the US “ARRA” economic stimulus package that’s set aside to encourage adoption of electronic medical records systems. (A Google search for “HIT stimulus ARRA billion” produces 25,700 hits.) Medical practices that have EMRs and put them to “meaningful use” will get higher reimbursement from the government.

When the stimulus package was passed by Congress, the term “meaningful use” was intentionally left to be clarified later. See David Kibbe’s comment here for three items that were specified. And here we are: the work is now underway to define and clarify that term. Many meetings are happening in Washington to get this done.

I believe, and many basically agree, that meaningful use should be defined to include full patient access to their data in EMR systems. Here’s why.

First, let’s look at the world for which we’re designing: 2020.

2020: The world for which we’re planning

The systems we design today will be in use a long time from now, so I suggest we look at the world as it will be in 2020, and how we’ll be using these systems then. What does that world look like?

We will all be ten years older. You will be ten years older; your children will be ten years old; your parents will be ten years older.

The internet will be ten years more advanced. If you think back to the dial-up world of ten years ago (1999), when browsers were just five years old, there’s been a huge amount of progress … and, significantly for this discussion, a lot of it’s related to having more access to our personal data online: banking, plane reservations, shopping, and more. Think how that will change in the next decade.

Handheld computers (smartphones) will be ten years more advanced. (More advanced? Heck, the iPhone was only introduced 28 months ago.)

Connected e-health devices will be out of their infancy: WiFi blood pressure monitors, bathroom scales, glucose monitors, you name it. It’s fairly certain that by then we’ll be able to use cheap devices that send routine data to some central storage place, where smart software (your choice of smart software) can send out alarms or reminders, your care team can view it … and you should be able to view it, too. And make notes on it.

Doctors will be ten years older. Fast Company magazine’s Doctor of the FutureJay Parkinson will be middle aged (Ha!). Our oldest doctors will be retired (or dead). Today’s youngest doctors will be well into their careers and owning practices; a new generation of providers will be practicing who were born after Amazon.com (1994). They have never known a world without household email. They expect everything to be online.

In this world, what kind of data access do we want? We need to build that into our design choices now. Why?

The product development cycle

It takes time to plan, design, code, test, install, and train on systems. And once that’s done, the decisions that are made will be with us for a long time – until vendors decide to go through that whole process again.

Sure, a lot of code gets written and updated fast. But if I’ve learned one thing about healthcare IT since I got in the e-patient game, it’s that healthcare systems are big, complex, and slow to change. These are not things that get re-engineered frequently.

Docs/nurses etc: how old are the systems you use today? Some are new, but many of you are using systems designed in 2000, right?

And here’s where regulatory requirements come in.

The impact of regulatory requirements

Some regulatory requirements profoundly affect product design. If a law is passed saying you can get a tax credit for a computer where the “Q” key is colored orange, vendors will offer that, because customers will buy it. Similarly, if a law requires that a system have a particular feature, people will only buy that, so vendors put it in the product plan, right from the get-go.

That’s the case with HIPAA: many systems are required by the government to be HIPAA compliant. So vendors design accordingly.

And so it is today with the definition of “meaningful use.” Providers will only receive stimulus money if the system they choose meets the definition of meaningful use. So the definition we choose today can have a profound impact on what you can do with your data far into the future.

My principles

Patient is a first-person word. Your time will come: someday it will be you, your child, your mother, your spouse on that hospital bed or at that roadside being tended by an EMT. The way to think about this is in the first person: when that time comes, what should be possible with “my data,” not “patients’ data.”

It’s my data. It’s my life that’s at stake. I have a right to seek the best care in the world, and if that means exporting a copy of my data from your system and taking it somewhere else, I have a right to do that..

Corollary: No more proprietary captive data.(Edited 11:20am EDT) We must put an end to the era where a system provider thinks the data they collect is their property. Lives are at stake. Whose data is it, anyway? Vendors must adapt to a world where they earn their margins by creating on-going value, not by holding data captive. This includes images (CT scans, MRIs, etc, at full diagnostic resolution) as well as lab results and everything else.Added 11:40am EDT: My opinion is that “whose data is it” applies to providers as well as system vendors. If you haven’t yet, consider what happened to Web guru Doc Searls last year when he couldn’t share his scan data with another MD.

Enable participatory medicine – doctor-patient collaboration. Make it possible for each party to view the same data. (Ideally, I’d like to enable collaboration tools such as online discussion of my medical records – but that’s beyond the scope of this post.)

Let each constituency say what works for them. Patients shouldn’t say what doctors need, and doctors shouldn’t mandate how patients should and shouldn’t describe things. Warning: experts on both sides should be able to comment on / warn the other about apparent errors. Docs must be able to say “Whoops, you overlooked this,” and patients must be able to say “Whoops, you overlooked this.” (See related discussion of “who will vet the vetters” in “Medpedia: who gets to say what info is reliable?”)

Recommendations

These are my personal recommendations, not necessarily those of e-patients.net or the Society for Participatory Medicine. (Hey you out there – what do you think? Participate in the comments! You count!)

Grant patients full access to their medical records. Exception: the best minds I know have said doctors need the ability to store private notes, and I can grant that. But I want full access to all my data: all the numbers, all the test results, all the radiology reports, everything.Added 11:45am: Among other things, the records might contain errors, and we can help clean them up.

Let me export my data and take it elsewhere. I have a right to seek the best care anywhere, even if it means going somewhere else. Systems must be designed to allow exporting data (and, of course, importing data). I know there are lots of details to be worked out. Let’s just start with this principle: it’s my data.

Enable the most able. Don’t dumb down the data. Allow different levels of viewing – simple, medium, expert. (Hint: let each group participate in creating the language, and let users vote it up or down.)

This is our golden moment. It’s not fundamentally hard to give patients access to their data, not any more than it’s hard for banks to give us access to our banking information. It took banks two or three generations to get it right, but the technology exists, and now it’s widespread. Let’s encourage EMR vendors to get it right on the first try, by defining meaningful use to include giving us full access to all our medical data.

A great organization called the Markle Foundation has recently issued a paper that lays out their thoughts on this issue. I like it, and so do the rest of the people on e-patients.net who’ve voiced an opinion in the back room. More on that Sunday. My post on that is here.

Related

16 Comments

Bring on the future. As someone living with several chronic conditions including polycystic kidney disease, electronic records along with doctors willing to engage in this new modality of medicine is somethign that interests me greatly. I am in Australia where nearly all doctors use electronic records, and pathology and imaging labs send results straight to the referring doctor’s system. That’s great but I’d like to take it a step further in that the labs should be able to send the results straight to ME as well. As it is I must get a printout from the doctor’s office and re-enter it into my own e-records.

It would be helpful if secure systems were set up so that one could log in to their own medical record from anywhere they deemed appropriate. I’d like to be able to set up viewing profiles, so for example if I went to a gastroenterologist they’d get my record presented in a certain way, with the most relevant information first, which would be different to the way a nephrologist would see it. Like tailoring your resume for different jobs. :) Security could be maintained perhaps through passwords sent by those new USB-stick based systems like the Yubikey (Google it).

Medicare.gov.au lets anyone who is eligible for Medicare (all citizens and most permanent residents and refugees) register to access online services. You can see what doctors you went to, what their fee was and how much Medicare refunded you. You can see your cumulative total towards the $ threshold whereafter Medicare will pay 80% of your out-of-pocket expenses. You can register as an organ donor. I’d like to see in the near future an electonic system that links your doctor and hospital records, your pharmacy records, and your Medicare records. I also think that other health professionals like dieticians, physiotherapists, and dentists should be able to add to the record, as should “alternative” medical practitioners. Probably a lot of drs wouldn’t like the alternative practioners doing so as it might add inappropriate legitimacy in their eyes, but the fact is that lots of people visit these alternatives and doctors need to know what they have prescribed and their justfications for doing so. In my ideal system, health practioners and the patient would be able to add comments and notes to this record thus encouraging discussion and collaboration.

I could write a whole lot more on this so I won’t hog the comments page but I will cut and paste and elaborate on my own blog. :)

Welcome, PKDNotes! I love your thinking and love seeing on your blog that you call yourself an active e-patient. Looks to me like you sure are.

Let us know when you’ve posted.

I love the idea of “viewer profiles” that selectively present information differently based on the viewer. I believe this could easily be done with XSL stylesheets – are you familiar with that concept? In fact I think it’s a *great* idea.

Great post, Dave. However, the interpretation of “meaningful use” is not as open ended as you suggest. The law (ARRA) actually does specify three examples of “meaningful use,” and they are
* The ability to do ePrescribing.
* Engagement in health information exchange to improve quality of care, e.g. care coordination.
* Reporting of quality and performance metrics, in a manner to be specified by the Secretary of HHS.

The common link between these three seemingly different uses of EHR technology is connectivity of health data to improve service quality.

E-Prescribing is essentially designed to promote care coordination between patients, doctors, and pharmacists. It uses EHR technology that is dedicated to exchange of data between physicians ordering medications, pharmacists who are filling these prescription orders, and patients who request refills and are dispensed medications for treatment of their conditions and diseases. All of these processes are easier, safer, more convenient, and less costly to perform using EHR technology than by paper or fax, and therefore we agree that this is a “meaningful use” of such technology.

Health information exchange between and among providers, especially when these providers are independent entities or exist in separate geographical locations, helps create continuity of patients’ experience by providing continuity of information flow and access where once there were only isolated silos of health data. There is widespread belief that health data sharing could improve care, safety, and decrease waste and duplication.

And quality reports are, in essence, statistical analyses of patient experience, sorted across many different variables: e.g., condition, acuity, physician, location. Providers submit the raw data for analysis and feedback, another kind of care coordination and communication activity, although the results are removed in many cases from direct patient care. Here too, we see that this feedback holds significant potential for improving care and eliminating unnecessary costs.

However, and this gets to your major points, what is NOT INCLUDED in “meaningful use” is any notion of communication, coordination, or collaboration between patients and their providers, or between patients and other consumers/patients.

This is clearly an oversight and needs to be addressed. The roles patients and consumers might play in any determination of “meaningful use” are important, but are left on HITECH’s sidelines. How can health IT policy enhance the patient’s health care experience and participation?

This is where concerned patients and physicians alike must unite to urge Dr. Blumenthal et al. to increase the scope of “meaningful use” to include the patients’ experience.

Thank you so much for that contribution, David. What you said is a perfect example of what I meant when I said I wanted to get it right, but it’s vast. :–) Your participation upgrades the discussion.

I’ll fix my wording when we iron this out. (Don’t I love these open discussions??) So let’s go:

You say it’s “not as open ended” as I suggest. My impression is that literally nothing is *stipulated* by the law, so for instance the three uses it mentioned are not at all required, and the law wasn’t meant to preclude anything else. If so, it sounds open-ended to me. Am I off?

But aside from the wording, there’s an equally big issue of how people are treating it in practical reality. That’s where it’s invaluable to hear from people who are actually in the game (you).

Dave: In my experience the language in a federal bill or law is put there for a purpose, and it’s quite explicitly stated in the ARRA that “meaningful use” includes the three examples I noted above. Therefore, I would find it really surprising if ONC and HHS did not include these three uses in their final rulings.

Having said that, the descriptions given in the law are somewhat vague. It’s important to define ePrescribing, information exchange, care coordination, and quality reporting if these are to be validated and rewarded by CMS or Medicaid.

Also, it’s very possible that ONC will add to the list of what may or must be meaningful uses. For example, use of clinical decision support of some kind. Or use of a PHR that makes health data available to the patients, as you have suggested.

Dave wrote: “It’s my data. It’s my life that’s at stake. I have a right to seek the best care in the world, and if that means exporting a copy of my data from your system and taking it somewhere else, I have a right to do that.”

Until there is a cultural change, then ‘my data’ means nothing because it is my understanding, please correct me if I am wrong, but the institutions OWN the data, patients MAY have access (patients’ rights). Except where does the power lie? Certainly not within the patients themselves and today it is not uncommon for patients to have to fight to receive copies of test results etc. The ‘change’ foundations need to bring the power of the people to a more elevated standing than seemingly as an add-on.

I won’t go into detail, but not less than a couple of weeks ago I asked for medical information. The information which I received was selectively sent, meaning that I KNOW FOR A FACT, that the information which was received and which I requested was not in fact all sent to me. Further, we are still using the privacy issue as an excuse. On the IT issue? I was asked if I would prefer fax or mail? I long ago disconnected my fax machine as redundant. It’s worth noting that this is a leading research centre.

So,it still remains today that unwell, unsophisticated patients and by extension their families will in the foreseeable future still be having access issues.

Meaningful is only useful if it starts and stops with the patients and families. It is my view, that institutions are valued partners, as long as institutions see themselves as partners (with patients). There are many organizations which are taking progressive steps forward, but the culture has to change first and that has been the largest stumbling block for many all along.

I believe and hope that the ‘younger’ generations will simply not tolerate a full focus inclusionary practice, no matter at what level. Pretty cynical I am afraid, but a learned experience both through the masses and personally.

It makes me ache to hear how far we are from the world I know is so possible.

You’re in Canada, if I recall correctly, so whatever we do in the US won’t immediately directly affect you. But the principles I talk about are universal, to me: universal human principles.

Yes, cultural change looks to be necessary to. Let us begin. Let us start refusing to play along with the idea that the data belongs to anyone other than us.

I won’t be surprised if we see a cottage industry spring up of people who take our faxed and mailed records and get them into a computer system that WE can manage, if the hospitals can’t get around to it. Good heavens how stupid is that, that we ordinary mortals can figure out how to do something that hospitals with their billions can’t? Let’s just get on with it.

I never worry about geography, Dave, as we all live in a global world now. It simply is irrelevant for the communities I am involved with (and the many of you, of course) because what is important has very little do with with where we live. To be quite blunt, the signs and symptoms and the living with and dying with cancer(s) are no different from that which individuals experience. However, whatever you do in the U.S. does affect us and vice versa, Dave, and I am happy to see, in the research at least, much more in the way of a global coordinated effort. So, yes, I totally agree – human universal principals and it was nice to see you speak of this.
I joined a particular effort some years ago believing that patients were the centre of the professed mandate. This week these efforts have come under substantial international criticism. that indeed. the philosphy is not working. (surprize) Fortunately, I gave myself a timeline as to how much I would contribute (volunteer) and how exactly much change I would need to see to continue. Am I committed, like the many of you? Of course, but often times the writing is on the wall, so to speak, very early on it is just recognizing it early that is the key.
I am tired of the games, but more importantly I am tired of the suffering and for some reason this has little impact on those for whom it should. If we could just abolish ego, money and politics….pipe dreams, obviously.
Maybe in my next life and yours we will have the final answer but in the interim we must be true to ourselves. Why is it that we just cannot say NO to stupid things and ideas?
This is an interesting short item I just came across:

The term ‘culture change’ came from the WHO’s Patient for Patient Safety – the question is how long does it take. The NPSF (U.S.) has now existed for over a decade and sure some improvements have taken place, but not even close in comparison to the suffering.
Sad world sometimes.

Everyone, I urge you to view the quick Slideshare presentation at the link Sandi included: http://tinyurl.com/cy4s6k It has an amazing overlap with last part of my post yesterday about the Markle Foundation’s work on meaningful use, particularly the thoughts on what it’ll take to get these important changes adopted.

When it comes to devices, I have my own feeling on that one too. I love technology and use it to the hilt and really promote patient involvement with health records,etc.

The part that worries me though is risk management’s use of devices, the insurers. There are already some scary inroads with employer insurance contracts, with cheaper rate incentives if the employee connects their iPhone or other device to report in their daily statistics, and this is not going to the patient’s doctor and only serves to interfere with the patient/doctor relationship. That puts a whole new spin on “meaningful use” and now Congress wants to allow more incentives for employers, but I don’t think they have looked at some of the technology that might come with it.

It’s kind of the “other” side we forget about sometimes as we are all focused in using technology for better healthcare and education is important in that area so people can see what it can do, but on the other hand to allow devices used simply to track and present statistics in real time on who should be covered for insurance is scary.

If I went out 2 weeks ago and let’s say had a lot to drink and my blood pressure after the event was tracked a little higher since that day, would I be looked at as a bigger risk and required to pay more on my share of the premiums? That is just a simple example, but some of this type of activity is already out there.

On the positive side, if I were monitoring my own, with my own device and saw the results in my PHR, it would perhaps signal me to make an appointment to see a doctor if it was elevated more than normal.

We have blue tooth inhalers on the horizon and so how will they be used? I know, lots of questions and we could end up with devices not only assessing us in real time, but driving us nuts in the process with alerts coming out our ears!

A couple of comments. I think this is a really good post. I agree very much with you and David Kibbe about the need to address what’s not included as part of the “meaningful use” definition — communication, coordination, and collaboration between patients & providers and also among patients. My hope is that these elements can be built into “meaningful use” not as an immediate requirement (which frankly isn’t practical) but as a longer term one. (The definition of “meaningful use” can be set to change to inlcude more requirements over time.)

Regarding the discussion above with Sandy re viewer profiles — it’s not just that we need health information to be presented in different levels of complexity, or to meet the needs of particular classes of professionals. Different patient populations also need info presented in different ways to respond to differences in primary language spoken, visual and other disabilities, cultural sensitivities, etc. I’ve done some work with the State of NY in communicating with the public about ehealth… different population groups need to be targeted in different ways. This requires a fair amount of work, but fortunately one thing technology is good at is customizing content for lots of different audiences.

Providers will only receive stimulus money if the system they choose meets the definition of meaningful use. So the definition we choose today can have a profound impact on what you can do with your data far into the future.

what about our rights not to be into a data base.
I guezz that if one person need to have her/his own record, put it on a chip and the person carries it to their doctors. The doc gets a private download of the past medical history and the person adds that visit to its chip. The patients continues carrying their own chip like drivers’license. what about we carry our own thing and NOT a government database. I dont want to be on no data base. isurances, hackars and who knows whi will always have more access than I to it.

Hi Mora – I might be missing something but how is this related to government databases?

(Regardless, I’m sure you know many others agree with you.)

And as I’m sure you know, that approach requires that any doctor or emergency room you might encounter will need the ability to read that chip. I’m not disagreeing with you, just pointing out some common arguments.

Also if I understand correctly, the current regulations will say you will have as much access as insurance etc – in fact that’s a principal point of the regs, as I understand it…